Eosinophilic Asthma
Conditions
Keywords
Exacerbations, Severe Asthma, EXHALE-2, EXHALE-3, EXHALE-4, Uncontrolled Asthma, Asthma Attack
Brief summary
The goal of this clinical trial\] is to evaluate the long term safety of dexpramipexole treatment in participants with severe asthma, aged ≥18 years, on Global Initiative for Asthma (GINA) 2021 \[GINA, 2021\] Step 4 or 5 therapy and who completed either of the Phase III studies EXHALE-2 or EXHALE-3.
Interventions
Oral administration of dexpramipexole tablet
Sponsors
Areteia Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Participants who completed the double-blind study intervention treatment period during either of the Phase III studies EXHALE-2 or EXHALE-3. 2. Participants capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 3. Negative urine pregnancy test for women of childbearing potential (WOCBP; after menarche) at the Baseline Visit/Day 1. 4. WOCBP (after menarche) must use either of the following methods of birth control, from the Baseline Visit/Day 1 through the End of Study Visit: 1. A highly effective form of birth control (confirmed by the investigator). Highly effective forms of birth control include: true sexual abstinence, a vasectomized sexual partner, Implanon, female sterilization by tubal occlusion, any effective intrauterine device (IUD), IUD/intrauterine system, levonorgestrel intrauterine system, or oral contraceptive. -OR- 2. Two protocol acceptable methods of contraception in tandem. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for ≥12 months prior to the planned date of the Baseline Visit/Day 1 without an alternative medical cause. The following age specific requirements apply: 3. Women \<50 years old will be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone levels in the postmenopausal range. 4. Women ≥50 years old will be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.
Exclusion criteria
1. Clinically significant change in health status during either of the Phase III studies EXHALE-2 or EXHALE-3 which in the opinion of the investigator would make the participant unsuitable for participation in this study. 2. Participants with allergy/intolerance to dexpramipexole or any of its excipients. 3. Participants who met permanent discontinuation criteria or permanently discontinued study treatment for any reason in either of the Phase III studies EXHALE-2 or EXHALE-3.. 4. Treatment with selected drugs known to have a substantial risk of neutropenia in the past 30 days. 5. Pregnant or breastfeeding women. 6. Males who are unwilling to use an acceptable method of birth control during the entire study period (ie, condom with spermicide).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Participants with a Treatment Emergent Adverse Event | 52 weeks | Summary of participants from the safety population who experienced an adverse event. |
| Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Clinical Laboratory Evaluations | 52 weeks | Summary of participants from the safety population who experienced potentially clinically significant postbaseline changes in hematology and chemistry results. |
| Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Vital Signs and Body Weight | 52 weeks | Summary of participants from the safety population who experienced potentially clinically significant postbaseline changes in vital signs (blood pressure, pulse rate, respiratory rate, and temperature) or body weight. |
| Number and Percentage of Participants with Potentially Significant Postbaseline Changes in Electrocardiogram Parameters | 52 weeks | Summary of participants from the safety population who experienced potentially significant postbaseline changes in electrocardiogram parameters: heart rate, PR, QRS and QTcF intervals. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Asthma Control Questionnaire-6 (ACQ-6) | Day 1 (baseline), Weeks 16, 32, and 52 | ACQ-6 is simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment. The 6-point self-administered scale has items measuring asthma symptoms and rescue inhaler use. The ACQ score is the mean of the questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). |
| Change in absolute eosinophil counts (AEC) | Day 1 (baseline), Weeks 16, 32, and 52 | Change from baseline, at Weeks 16, 32, and 52. |
| Severe Asthma Exacerbations | Averaged across 52 weeks | Annualized rate of severe asthma exacerbations over 52 weeks |
Countries
Argentina, Brazil, Bulgaria, Georgia, Japan, Mexico, North Macedonia, Poland, Romania, Serbia, South Africa, South Korea, Ukraine, United Kingdom, United States
Outcome results
None listed